Jun122018

Currently in Democratic Republic of the Congo (DRC), 25 people are suspected to have already died from Ebola in the Equateur province. Four cases have reached the provincial capital of Mbandaka, prompting fears that DRC is on the cusp of an urban epidemic.

A few years ago, in the 2014 West African Ebola epidemic, outbreaks in urban areas quickly spread to 10 countries, with a case showing up as far away as Dallas, Texas. There was no vaccine available then, and laboratory confirmation of diagnosis took three months. More than 28,600 people were infected and 11,000 died.

Thankfully, today a safe and highly effective vaccine was deployed within 10 days of the outbreak, a vaccine developed thanks to a United States anti-terrorism project that started—for me—with white powder in a Senate office.

Bipartisanship in 2004 Laid the Groundwork

As a physician, I am familiar with how deadly biological agents can be, but in February 2004 I got firsthand experience. When I was serving as Senate Majority Leader, an intern found white powder in my office near the mail. Three years earlier, anthrax was mailed to several news media offices and two Senate offices, ultimately claiming the lives of five people. A few months earlier a letter bound for the White House was discovered with a vial of ricin. The powder in my office also turned out to be the deadly plant toxin ricin as well. Thankfully no one was hurt, though three congressional office buildings were closed for days.

It had never been more clear to me how vulnerable America is to bioterrorism, and my colleagues on both sides of the aisle redoubled our efforts to promote the development of new tools to protect America.

We in Congress passed the Project BioShield Act, a $5.6 billion research effort to develop and acquire medical vaccines and treatments to protect against chemical, biological, radiological, and nuclear (CBRN) attacks. In July 2004, when President George W. Bush signed the Project BioShield legislation, I was hopeful it would help protect the United States. The legislation, “would go a long way toward strengthening our nation’s defenses against the threat of anthrax, botulinum toxin, Ebola, plague, and smallpox – some of the most dangerous weapons of mass destruction known to man,” I said at the time.

The demand for these types of drugs and vaccines is often non-existent until the crisis is upon us—prior to the anthrax attacks of 2001, we had not seen a case of anthrax inhalation on U.S. soil for a quarter of a century. Congress passed Project BioShield to address this market failure by pre-emptively funding medical countermeasures while they are still in development, creating a demand by building up vaccine stockpiles in preparation for a bioterrorism attack, as well as authorizing the use of promising treatments that don’t yet have FDA approval in emergency situations.

In December 2006, in my final month as Senate Majority Leader, we passed the Biomedical Advanced Research and Development Authority (BARDA) to strengthen BioShield by creating a dedicated agency within the U.S. Department of Health and Human Services focused on the procurement and development of CBRN medical countermeasures.

To date, BioShield funding has facilitated the procurement of 27 medical countermeasures for diseases and other agents considered national security threats, including products for smallpox, anthrax, and botulinum, with seven products that were funded in the development stage clearing the high hurdle of FDA approval.

From Ricin and Anthrax to Ebola

For its part, BioShield made Ebola one of a number of pathogens prioritized as a potential bioterrorism threat. In doing so, U.S. leadership emboldened other ally governments to also invest heavily in counter-bioterrorism. This represented a huge boost in research for a deadly disease that was otherwise neglected, ultimately leading to the creation of 11 potential Ebola vaccines.

But when the 2014 West African epidemic hit, none of these potential vaccines had yet made it to market. This was in part because, in the years since I left Washington, Project BioShield downgraded the threat Ebola posed because it was deemed too difficult to weaponize. Federal dollars were no longer being put towards creating a demand for an Ebola countermeasure, and promising vaccines sat gathering dust for nearly a decade with no funding to advance them through the lengthy licensing process.

Making a Market: Gavi Goes the Last Mile

Luckily, an organization run by my good friend Dr. Seth Berkley took up this cause. Created in 2000 at the World Economic Forum in Davos with funding from the Gates Foundation, Gavi, the Vaccine Alliance, responded quickly to the African Ebola epidemic four years ago. The Gavi board committed up to $390 million in 2014 for the purchase of Ebola vaccines, essentially jumpstarting stalled work that BioShield had started. In one move, Gavi created a market for vaccines worth millions, and is the reason the promising rVSV-ZEBOV vaccine developed by the Canadian National Microbiology Laboratory and licensed by Merck is now being quickly deployed in Democratic Republic of the Congo.

Gavi achieved this through an innovative financing mechanism called an Advanced Purchase Commitment, offering Merck a legally binding commitment of $5 million to buy doses of licensed vaccines when they became available. Even though Merck’s vaccine is still in the “investigational stage,” it has proven highly effective to date in clinical trials and on the ground. The Gavi team had the foresight to structure the agreement so that investigational doses would be made available if an outbreak occurred during the licensing process.

And now, because of Gavi’s investment and the bold leadership from the World Health Organization and quick response of Médecins Sans Frontières International, the vaccine has been distributed and administered to the people who need it. In a matter of days, over 1,100 people considered at risk have been vaccinated!

Advancing Vaccines and Ensuring Emergency Preparedness in an Outbreak: Next Steps

When we passed Project BioShield in 2004, the biggest challenge was the creation of a dedicated 10-year long funding stream, which was critical to convincing industry to invest in risky, low-profit drug development for rare diseases and pathogens that might only be seen in a bioterror attack. Unfortunately, this funding has been chipped away and since 2014, it has been subjected to the annual Congressional budget process, leaving it vulnerable to big swings in funding and deterring private sector research and development. In a Bipartisan Policy Center report released this February, authors former Senators Judd Gregg (R-NH) and Tom Daschle (D-SD) recommended several possible funding strategies for Project BioShield to “demonstrate that developing and procuring medical countermeasures will be a long-term priority for the United States.” The House and Senate have the opportunity to shore up BioShield funding this year when they consider the renewal of the Pandemic and All Hazards Preparedness Act. Providing a stable, dedicated funding stream is vital to continue the BioShield mission: to prepare for threats not yet addressed and maintain stockpiles critical for emergency response.

The U.S. also learned from the 2014 Ebola epidemic. Last year, BARDA committed Project BioShield funding to four companies in the late stages of developing an Ebola vaccine, providing support to advance these treatments to the FDA for approval. The BARDA funding is a powerful complement to Gavi’s contributions. Together, these strategic investments may be the final push needed to get an Ebola vaccine approved for licensing for public use. We must also learn from Gavi’s proactive, collaborative approach to driving research over the finish line. Outbreaks of known and new diseases are, and will continue to be, an evolutionary certainty. It’s time for forward-thinking prevention.

Truthfully, in our globalized society, we can no longer count on outbreaks being locally or regionally contained. As we saw with Ebola and later Zika, one nation’s challenge can quickly become a global problem. Investing in global health reduces the spread of diseases, improves our nation’s standing in the world, and serves as currency for peace. This small sliver of our federal budget (less than 0.5%) pays life-saving dividends as it funds the infrastructure and trains the health workers that are the backbone in responding to public health crises. We must protect our citizens from bioterrorism and dangerous disease epidemics—the goal of Project BioShield—but we will fall short of this goal if we don’t look outward and invest in health beyond our borders.